Variable data usage personal medical system and method

ABSTRACT

A variable data usage personal medical system including a self-care device attached to a patient, and operable to generate self-care device data and to transmit the self-care device data at a fixed interval; a cellular communication device operable to receive and store the transmitted self-care device data, to register a count at an interval counter for each of the fixed intervals in which the transmitted self-care device data is received, to generate a data cellular packet from overhead plus the stored self-care device data when the interval counter equals a fixed interval index, and to transmit the data packet; and a cloud infrastructure operably connected to the cellular communication device over a cellular network, and operable to receive, process, and store the transmitted data packet. The cloud infrastructure is operable to transmit a value for the fixed interval index to the cellular communication device for storage.

RELATED APPLICATION

The present disclosure is a continuation of U.S. patent application Ser.No. 13/904,343 filed on May 29, 2013, the contents of which are hereinincorporated by reference in their entirety.

TECHNICAL FIELD

The technical field of this disclosure is personal medical systems,particularly, variable data usage personal medical systems and methods.

BACKGROUND OF THE INVENTION

Advances in electronics and telemetry have resulted in theminiaturization of medical devices such that medical devices whichpreviously required large stationary equipment can now be worn about theperson, who can be monitored or receive treatment while pursuing normaldaily tasks.

One area of such advances has been in the treatment of diabetes. Anestimated twenty-six million people in the United States, or about 8% ofthe population, have diabetes. This percentage is expected to increasein the near-term as the population ages. Wearable glucose monitors andinsulin pumps have been developed which allow persons under treatmentfor diabetes to be monitored and receive insulin while carrying on theirday-to-day tasks.

Wearable medical devices oftentimes communicate with a remote computersystem over a cellular network. Data, such as a glucose reading or pumpinformation, is obtained at the person under treatment then sent to thecomputer system periodically for analysis. Unfortunately, data is oftentransmitted at a regular frequency which may be higher than what isrequired. Sending a large amount of data over a cellular network isexpensive. Also, sending data too often can deplete the batteries on thepersonal medical device.

Other problems arise with the treatment of data received at the remotecomputer system. The data may not be current, making it unreliable andcausing potential misdiagnosis of ongoing status. Further, alarmsreceived at the remote computer system may be minimal, providinginsufficient information on which to take appropriate corrective action.

It would be desirable to have a variable data usage personal medicalsystem that would overcome the above disadvantages.

SUMMARY OF THE INVENTION

One aspect of the invention provides a variable data usage personalmedical system for use with a patient including a self-care deviceattached to the patient, the self-care device being operable to generateself-care device data and to transmit the self-care device data at afixed interval; a cellular communication device operably connected tothe self-care device, the cellular communication device being operableto receive and store the transmitted self-care device data, to registera count at an interval counter for each of the fixed intervals in whichthe transmitted self-care device data is received, to generate a datacellular packet from overhead plus the stored self-care device data whenthe interval counter equals a fixed interval index, and to transmit thedata packet; and a cloud infrastructure operably connected to thecellular communication device over a cellular network, the cloudinfrastructure being operable to receive, process, and store thetransmitted data packet. The cellular communication device is operableto store the fixed interval index and the cloud infrastructure isoperable to transmit a value for the fixed interval index to thecellular communication device for storage.

Another aspect of the invention provides a method of personal medicalvariable data usage for a patient including transmitting a value for afixed interval index remote from the patient; storing the fixed intervalindex at the patient; generating self-care device data for the patient;transmitting the self-care device data at a fixed interval; receivingand storing the transmitted self-care device data; registering a countat an interval counter for each of the fixed intervals in which thetransmitted self-care device data is received; generating a datacellular packet from overhead plus the stored self-care device data whenthe interval counter equals the fixed interval index; transmitting thedata packet from the patient over a cellular network; and receiving,processing, and storing the transmitted data packet remote from thepatient.

Another aspect of the invention provides a system of personal medicalvariable data usage for a patient including means for transmitting avalue for a fixed interval index remote from the patient; means forstoring the fixed interval index at the patient; means for generatingself-care device data for the patient; means for transmitting theself-care device data at a fixed interval; means for receiving andstoring the transmitted self-care device data; means for registering acount at an interval counter for each of the fixed intervals in whichthe transmitted self-care device data is received; means for generatinga data cellular packet from overhead plus the stored self-care devicedata when the interval counter equals the fixed interval index; meansfor transmitting the data packet from the patient over a cellularnetwork; and means for receiving, processing, and storing thetransmitted data packet remote from the patient.

The foregoing and other features and advantages of the invention willbecome further apparent from the following detailed description of thepresently preferred embodiments, read in conjunction with theaccompanying drawings. The detailed description and drawings are merelyillustrative of the invention, rather than limiting the scope of theinvention being defined by the appended claims and equivalents thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a variable data usage personal medicalsystem made in accordance with the invention.

FIG. 2 is a schematic diagram of self-care devices and a cellularcommunication device for a variable data usage personal medical systemmade in accordance with the invention.

FIG. 3 is a timing chart of communications for a variable data usagepersonal medical system made in accordance with the invention.

FIG. 4 is a flow chart of a method of personal medical variable datausage for a patient in accordance with the invention.

FIG. 5A-5I is a table of alarms and accompanying data for a variabledata usage personal medical system made in accordance with theinvention.

DETAILED DESCRIPTION

FIG. 1 is a block diagram of a variable data usage personal medicalsystem made in accordance with the invention. The variable data usagepersonal medical system 100 is designed for use with a patient andincludes a self-care device 110, a cellular communication device 120,and a cloud infrastructure 130. In this example, the variable data usagepersonal medical system 100 also includes an optional display device140. The variable data usage personal medical system 100 allows thecloud infrastructure 130 to control the time interval at which thecellular communication device 120 communicates data from the self-caredevice 110 to the cloud infrastructure 130.

The self-care device 110 can be attached to the patient and is designedto be carried or worn by a patient. The self-care device 110 can be anypersonal medical device which delivers therapy to a patient and/ormonitors a physiological parameter of the patient. Exemplary self-caredevices include pumps, cell pumps, continuous glucose monitors, and thelike. In one example, the self-care device 110 is an insulin deliverydevice. In another example, the self-care device 110 is a continuousglucose monitoring (CGM) device. In one embodiment, the self-care device110 can both deliver therapy and monitor a physiological parameter. Oneexample of such a device would be a paired insulin delivery and CGMdevice. Those skilled in the art will appreciate that the self-caredevice 110 can be any self-care device as desired for a particularapplication. The self-care device 110 generates self-care device data115 and transmits the self-care device data 115 to the cellularcommunication device 120 at fixed intervals.

The cellular communication device 120 is operably connected to theself-care device 110. The cellular communication device 120 is a radioprotocol converter and repeater device. The cellular communicationdevice 120 stores the self-care device data 115 received by the cellularcommunication device 120 from the self-care device 110. The link betweenthe cellular communication device 120 and the self-care device 110 canbe wired or wireless, using standard protocols such as 802.11b/g/n. Theradio protocol conversion can be stored in firmware in the cellularcommunication device 120. Exemplary cellular communication devicesinclude CloudPost™ glucose monitors and remote controllers therefor,controllers, display meters, mobile phones, on-body communicators,on-body repeaters, and the like. In one embodiment, the cellularcommunication device 120 can request that the self-care device 110 senddata stored in the self-care device 110 to provide the data backfillwhen the connection between the self-care device 110 and the cellularcommunication device 120 has been disconnected such that the cellularcommunication device 120 has not been receiving the self-care devicedata 115 from the self-care device 110. Thus, the cellular communicationdevice 120 maintains a complete data record. In one embodiment, thecellular communication device 120 can be combined and integrated in asingle package with the self-care device 110.

The cellular communication device 120 can register a count at aninterval counter for each of the fixed intervals in which thetransmitted self-care device data 115 is received. The interval countercan be incremented or decremented as desired for a particularapplication. When the interval counter equals a fixed interval indexprovided by the cloud infrastructure 130 and stored in the cellularcommunication device 120, the cellular communication device 120 cangenerate a data cellular packet 125, which includes the self-care devicedata stored in the cellular communication device 120 since data was lastsent to the cloud infrastructure 130 plus overhead. The overhead caninclude information about the particular data cellular packet 125, suchas identifiers, encryption keys, and the like. Those skilled in the artwill appreciate that in the art will appreciate that the overhead caninclude any information desired for a particular application tofacilitate communication between the cellular communication device 120and the cloud infrastructure 130. The data cellular packet 125 is sentfrom the cellular communication device 120 to the cloud infrastructure130 over a cellular network, i.e., a mobile radio network in which eachland area is served by one or more local radio transceivers. In oneembodiment, the cellular communication device 120 can store the datacellular packets when communication is lost between the cellularcommunication device 120 in the cloud infrastructure 130, and thecellular communication device 120 can send the stored data cellularpackets when communication is restored.

The cloud infrastructure 130 receives the data cellular packet 125 fromthe cellular communication device 120, and can generate display data 135from the data cellular packets received for transmission to the displaydevice 140. The cloud infrastructure 130 can include a data center 132,a cloud application 134, and a database 136. Those skilled in the artwill appreciate that the cloud infrastructure 130 can be a single deviceor can include multiple or distributed interconnected componentsperforming the functions of the data center 132, the cloud application134 and the database 136. The data cellular packet 125 can be receivedby the data center 132, processed by the cloud application 134, andstored in the database 136.

The cloud infrastructure 130 determines the value of the fixed intervalindex, which controls how often the cellular data packets aretransmitted from the cellular communication device 120 to the cloudinfrastructure 130. The cloud infrastructure 130 also transmits thevalue of the fixed interval index to the cellular communication device124 storage in the cellular communication device 120. The cellularcommunication device 120 counts the number of times self-care devicedata 115 is received from the self-care device 110 by registering acount at an interval counter, then transmits the data cellular packet125 when the interval counter equals the fixed interval index. The valueof the fixed interval index can be selected as desired for a particularapplication. In one embodiment, the value of the fixed interval indexcan be a fixed integer. For example, the fixed integer can be selectedbased on factors such as medical condition and history of a particularpatient, statistical analysis of patient group experience, or the like.In another embodiment, the value of the fixed interval index can beselected by the cloud infrastructure 130 based on activity in thevariable data usage personal medical system 100, such as viewing data onthe display device 140. In another embodiment, the value of the fixedinterval index can be selected based on communication costs, so that thedata cellular packets are transmitted from the cellular communicationdevice 122 the cloud infrastructure 130 more often when communicationcosts are low. Exemplary cloud infrastructures include CareLink®Personal Software, SMS aggregators, servers, computers, and the like.

The display device 140 can be any human machine interface incommunication with the cloud infrastructure 130 capable of receiving anddisplaying the display data 135. Exemplary displays for display devices140 include displays on dedicated display devices, consumer devices,mobile phones, computers (e.g., desktops, laptops), computer tablets,Internet-enabled televisions, and the like. In one embodiment, thedisplay device 140 can be integrated with the self-care device 110and/or the cellular communication device 120.

The display device 140 can be updated continuously or periodically. Thedisplay device 140 can generate a display device data request when thedisplay device 140 is enabled, i.e., when the display device isenergized and/or being used. The display device data request istransmitted from the display device 140 to the cloud infrastructure 130.In one continuous update embodiment and in response to the displaydevice data request, the cloud infrastructure 130 sends a wake upmessage to the cellular communication device 120, followed by repeatedcloud infrastructure data requests to the cellular communication device120. In response to the repeated cloud infrastructure data requests, thecellular communication device 120 sends a data cellular packet 125 tothe cloud infrastructure 130 every time the self-care device 110 sendsthe self-care device data 115 to the cellular communication device 120,i.e., each time the interval counter equals the fixed interval index.The cloud infrastructure 130 then generates continuous display data fromthe data cellular packets and provides the display data 135 to thedisplay device 140, providing a continuous update of the display device140.

In another continuous update embodiment, the cellular communicationdevice 120 can include a continuous communication index that isresponsive to a toggle command from the cloud infrastructure 130. Thedisplay device 140 can generate a display device data request when thedisplay device is enabled and transmit the display device data requestto the cloud infrastructure 130. In response, the cloud infrastructure130 can send a toggle command to the cellular communication device 120to toggle the value of a continuous communication index. This, in turn,toggles the operating mode of the cellular communication device 120 fromthe current mode to the alternate mode, i.e., from continuous to normalor from normal to continuous. In the normal mode, the fixed intervalindex governs how often the cellular communication device 120 sends thedata cellular packet 125 to the cloud infrastructure 130. In thecontinuous mode, the cellular communication device 120 sends the datacellular packet 125 to the cloud infrastructure 130 every time thecellular communication device 120 receives self-care device data 115from the self-care device 110. The cloud infrastructure 130 can sendanother toggle command to the cellular communication device 120 thatchanges the value of the continuous communication index back to itsinitial value, for example, returning the cellular communication device120 to the normal mode when the display device 140 is turned off.

In yet another continuous update embodiment, the fixed interval indexcan be changed to provide a continuous update. The display device 140can generate a data interval increase request when the display device140 is enabled. The data interval increase request is transmitted fromthe display device 140 to the cloud infrastructure 130, which sends awake up message and new value for the fixed interval index to thecellular communication device 120. The new value is typically less thanthe present value of the fixed interval index, so that the data cellularpackets 125 are sent to the cloud infrastructure 130 more often to keepthe display device 140 current. In one example, the new value is one, sothat a data cellular packet 125 is transmitted to the cloudinfrastructure 130 every time the cellular communication device 120receives self-care device data 115 from the self-care device 110.

In a periodic update embodiment, the display device 140 can generate adisplay device data request when the display device is enabled andtransmit the display device data request to the cloud infrastructure130. In response to the display device data request, the cloudinfrastructure 130 sends the display data 135 generated from the mostrecent data cellular packet 125 received at the cloud infrastructure 130to the display device 140. In response to the display device datarequest, the cloud infrastructure 130 also sends a single cloudinfrastructure data request to the cellular communication device 120. Inresponse to the single cloud infrastructure data request, the cellularcommunication device 120 sends a data cellular packet 125 containing thelatest self-care device data 115 stored in the cellular communicationdevice 120 to the cloud infrastructure 130, which generates latestdisplay data 135 from the data cellular packet 125 and sends the latestdisplay data 135 to the display device 140. Thus, the display device 140displays the most recent data received by the cloud infrastructure 130with updated data requested from the cellular communication device 120.

The improvement in data usage with the variable data usage personalmedical system can be illustrated by looking at data usage at differentfixed interval indices. As described above, the data packet includesoverhead providing information about the transmission and a payloadincluding stored self-care device data. When the overhead requires 565bits and the payload taken every 5 minutes is 107 bits, the data usageis 5.8 Mb per month when the fixed interval index causes the five minutedata packet of 672 bits [565+107] to be sent every 5 minutes. Using thesame 565 bits for overhead plus 107 bits of payload taken every 5minutes, the data usage is 1.7 Mb per month when the fixed intervalindex causes the thirty minute data packet of 1207 bits [565+(6*107)] tobe sent every 30 minutes.

FIG. 2 is a schematic diagram of self-care devices and a cellularcommunication device for a variable data usage personal medical systemmade in accordance with the invention. In this example, the patient 200and is wearing two self-care devices, a therapy administration device210 and a physiological monitoring device 220, both of which are inwired and/or wireless communication with a cellular communication device230. In one embodiment, the therapy administration device 210 is aninsulin delivery device and the physiological monitoring device 220 is acontinuous glucose monitoring (CGM) device. The self-care device asdefined herein can be any personal medical device designed to be carriedor worn by a patient.

FIG. 3 is a timing chart of communications for a variable data usagepersonal medical system made in accordance with the invention. Thecommunications occur between the components described above: a self-caredevice 310, a cellular communication device 320, a cloud infrastructure330, and a display device 340.

At 315, the self-care device 310 sends self-care device data to thecellular communication device 320 at a fixed interval 312, such as 5minutes in this example. The cellular communication device 320 receivesand stores the self-care device data, and increments and intervalcounter each time the self-care device data is received.

At 325, the cellular communication device 320 sends a data cellularpacket to the cloud infrastructure 330 when the interval counter equalsa fixed interval index. The data cellular packet is generated by thecellular communication device and includes overhead plus storedself-care device data. In this example, the fixed interval index is 6 sothat the data cellular packet is transmitted to the cloud infrastructure330 every 30 minutes. At 326, the cloud infrastructure 330 can return anoptional data received response to the cellular communication device320. The cycle of data transfer from the self-care device 310 to thecellular communication device 320, followed by the less frequenttransfer of data from the cellular communication device 320 to the cloudinfrastructure 330 can be repeated indefinitely.

When the display device 340 is enabled, the display device 340 sends adisplay device data request to the cloud infrastructure 330 at 345. Thecloud infrastructure 330 sends a wake up message to the cellularcommunication device 320 in response at 335. The cellular communicationdevice 320 sends the latest data cellular packet to the cloudinfrastructure 330 in response to the wake up message at 322. The cloudinfrastructure 330 generates display data including the latest datacellular packet and transmits the display data to the display device 340at 332. At 324, the cellular communication device 320 transmits a datacellular packet to the cloud infrastructure 330 when the intervalcounter equals the fixed interval index.

After a fixed interval, the display device 340 sends another displaydevice request to the cloud infrastructure 330 and the cycle is repeatedwith the return of the latest display data to the display device 340.When the display device 340 is disabled, display data is no longertransmitted from the cloud infrastructure 330 to the display device 340,and the variable data usage personal medical system returns to the cycleof data transfer from the self-care device 310 to the cellularcommunication device 320, followed by the less frequent transfer of datafrom the cellular communication device 320 to the cloud infrastructure330.

Those skilled in the art will appreciate that the communications for thevariable data usage personal medical system can include securityfeatures as desired for a particular application. In one example,devices which desire to communicate, such as the cellular communicationdevice and the cloud infrastructure, can employ a handshake protocol toverify each other's identity before data is sent between them. Inanother example, devices can establish a virtual private network acrosspublicly accessible communications networks. In yet another example, thedata being transmitted can be encrypted to verify integrity andsecurity.

FIG. 4 is a flow chart of a method of personal medical variable datausage for a patient in accordance with the invention. The method 400includes transmitting a value for a fixed interval index 410 remote fromthe patient; storing the fixed interval index 420 at the patient;generating self-care device data for the patient 430; transmitting theself-care device data at a fixed interval 440; receiving and storing thetransmitted self-care device data 450; registering a count at aninterval counter for each of the fixed intervals 460 in which thetransmitted self-care device data is received; generating a datacellular packet 470 from overhead plus the stored self-care device datawhen the interval counter equals the fixed interval index; transmittingthe data packet from the patient over a cellular network 480; andreceiving, processing, and storing the transmitted data packet 490remote from the patient. The term “at the patient” as defined hereinmeans that the action occurs on, in, or near the patient; the term“remote from the patient” as defined herein means that the action occursaway from the body of the patient at a distance. For example, storing afixed interval index at the patient can be performed by storing thefixed interval index in a cellular communication device, whilereceiving, processing, and storing the transmitted data packet remotefrom the patient can be performed in the cloud infrastructure. In oneembodiment, the method 400 can further include generating display datafrom the transmitted data packet, and presenting the display data. Inanother embodiment, the method 400 can further include transmitting analarm packet with accompanying data from the patient, and optionallyadjusting therapy for the patient based on the accompanying data. Themethod 400 can be carried out on a variable data usage personal medicalsystem as described for FIG. 1.

FIG. 5A-5I is a table of alarms and accompanying data for a variabledata usage personal medical system made in accordance with theinvention. The table includes the alarm number 510, the alarm name 520with definition, the notification text message 530, and the accompanyingdata 540. When the self-care device detects an unusual condition andsends an alarm packet to the cloud infrastructure through the cellularcommunication device, the alarm packet includes the alarm number as anidentifier plus the accompanying data for use in making therapyadjustments. Accompanying data as defined herein is any data availableat the cellular communication device which is useful to the cloudinfrastructure in making therapy adjustments. For example, referring toalarm number A101 of FIG. 5A, the alarm is transmitted from theself-care device when the self-care device measures glucose above a userspecified high limit. The accompanying data to be sent in the alarmpacket includes data useful in making therapy adjustments, such asinformation concerning time, injection history, glucose measurementhistory, patient activity history, and the like. Those skilled in theart will appreciate that alarms and accompanying data other than theexamples of FIG. 5A-5I can be used as desired for a particularapplication. For example, the accompanying data can be used for therapymanagement by patients, health care providers, health service payors,caregivers, and the like.

It is important to note that FIGS. 1-5I illustrate specific applicationsand embodiments of the invention, and are not intended to limit thescope of the present disclosure or claims to that which is presentedtherein. Upon reading the specification and reviewing the drawingshereof, it will become immediately obvious to those skilled in the artthat myriad other embodiments of the invention are possible, and thatsuch embodiments are contemplated and fall within the scope of thepresently claimed invention.

While the embodiments of the invention disclosed herein are presentlyconsidered to be preferred, various changes and modifications can bemade without departing from the spirit and scope of the invention. Thescope of the invention is indicated in the appended claims, and allchanges that come within the meaning and range of equivalents areintended to be embraced therein.

1. A system comprising: a self-care device of a patient operablyconnected to a communication device of the patient, wherein thecommunication device is operably connected to a cloud infrastructure,the self-care device being operable to: generate self-care device data;and transmit the self-care device data to the communication device at afixed interval, wherein the cloud infrastructure transmits a value for afixed interval index to the communication device, wherein thecommunication device registers a count at an interval counter for eachfixed interval in which the transmitted self-care data is received andwherein the communication device communicates a data packet, whichincludes the self-care device data, to the cloud infrastructure inresponse to the count at the interval counter being equal to the fixedinterval index.
 2. The system of claim 1, wherein the self-care devicefurther comprises a link between the self-care device and thecommunication device, wherein the link further comprises a wired or awireless connection.
 3. The system of claim 1, wherein the self-caredevice is operable to, in response to a request from the communicationdevice, send data stored in the self-care device to the communicationdevice.
 4. The system of claim 1, wherein the self-care device and thecommunication device are combined and integrated in a single package. 5.The system of claim 1, wherein in response to the count at the intervalcounter being equal to the fixed interval, the communication devicegenerates the data packet that includes the self-care device data plusoverhead.
 6. The system of claim 1, wherein the data packet is sent fromthe communications device to the cloud infrastructure over a network. 7.The system of claim 1, further comprising a display device operable toreceive and display data from at least one data packet.
 8. The system ofclaim 1, wherein the value for the fixed interval index is a fixedinteger.
 9. The system of claim 1, wherein the value for the fixedinterval index is selected based on at least one of a medical conditionand history of the patient, statistical analysis of a patient groupexperience, activity in the system, or communication costs.
 10. Aself-care device that attaches to a patient, the self-care devicecomprising: a communication link operable to communicate with acommunication device, the self-care device operable to: generateself-care device data; and transmit the self-care device data to thecommunication device at a fixed interval, wherein the communicationdevice registers a count at an interval counter for each fixed intervalin which the transmitted self-care data is received, wherein thecommunication device communicates a data packet, which includes theself-care device data from the self-care device, to a cloudinfrastructure in response to the count at the interval counter beingequal to a value for a fixed interval index received from the cloudinfrastructure.
 11. The self-care device of claim 10 further comprisinga personal medical device that delivers therapy to the patient.
 12. Theself-care device of claim 11, wherein the personal medical devicedelivers insulin to the patient.
 13. The self-care device of claim 10further comprising a personal medical device that monitors aphysiological parameter of the patient.
 14. The self-care device ofclaim 13 wherein the personal medical device is a continuous glucosemonitoring (CGM) device.
 15. A method comprising: generating, by aself-care device, self-care device data for a patient; and transmitting,by the self-care device, the self-care device data to a communicationdevice at a fixed interval, wherein a cloud infrastructure transmits avalue for a fixed interval index to the communication device, whereinthe communication device registers a count at an interval counter foreach fixed interval in which the transmitted self-care data is received,and wherein the communication device communicates a data packet, whichincludes the self-care device data, to the cloud infrastructure inresponse to the count at the interval counter being equal to the fixedinterval index.
 16. The method of claim 15, wherein the transmittingfurther comprises transmitting the self-care device data to thecommunication device approximately every 5 minutes.
 17. The method ofclaim 15, wherein, in response to the transmitting, the communicationdevice receives and increments the interval counter each time theself-care device data is received.
 18. The method of claim 15, whereinthe transmitting comprises a cycle of data transfer from the self-caredevice to the communication device that is followed by a less frequenttransfer of data from the communication device to the cloudinfrastructure.
 19. The method of claim 15, further comprising sending,by the self-care device, in response to detecting an unusual condition,an alarm packet to the cloud infrastructure through the communicationdevice.
 20. The method of claim 19, wherein the alarm packet furthercomprises an identifier plus accompanying data for use in making therapyadjustments.